Mon.Nov 13, 2023

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FDA Grants Priority Review to Liso-Cel in Relapsed/Refractory CLL/SLL

Drug Topics

The FDA acceptance marks the first step in addressing the unmet need for a lasting treatment option for patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

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FDA Expands Indication of Regional Analgesic to Reduce Postsurgical Pain Without Opioids

Pharmacy Times

Bupivacaine liposome injectable suspension was shown to reduce opioid use after surgery and significantly improve pain.

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First OTC Rapid Antigen Test for COVID-19 Cleared By FDA

Drug Topics

The test is also the first OTC rapid antigen test cleared for any infectious disease.

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Study suggests Covid rebound is far more common with Paxlovid than without

STAT

A small and preliminary study published Monday seems to indicate that patients receiving the drug Paxlovid are far more likely to experience Covid rebound than those who did not take it. That conclusion runs counter to previous statements by Pfizer, which makes Paxlovid, and by researchers at the Food and Drug Administration who have argued that while it is not uncommon for people with Covid to have symptoms reemerge after they seem to have recovered, it is not clear that Paxlovid increases the

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Study Findings Challenge Previously Considered Maternal Depression Timeline

Drug Topics

New study findings conflict with long-understood associations between maternal depression and the postpartum period and highlight the potential need for public health policy revisions.

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AMA urges coverage of obesity treatments as payers balk at costs

STAT

WASHINGTON – The American Medical Association called on insurance companies, employers, and government programs to cover obesity treatments even as many remain reluctant to pay for them, fearing the costs of covering the drugs at a mass scale. The large physicians’ lobbying group voted to pass a resolution at the association’s interim meeting Monday saying it will “urge all payers to ensure coverage parity for evidence-based treatment of obesity, including FDA- approv

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The U.K. just cleared a drug to prevent breast cancer. U.S. women may not know it’s already an option

STAT

The news that the U.K. has approved a preventive drug for post-menopausal women at risk of developing breast cancer wasn’t a shock to breast medical oncologist Abenaa Brewster. But the fact that a patient in her breast cancer prevention clinic hadn’t ever heard of such a possibility before was. “I thought to myself, ‘Oh, my God, I can’t believe a woman in America is being educated about preventive therapy from European use,’ because for the last 25 years

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Data Show Effect of Dietary Sodium Reduction on Blood Pressure Was Comparable to First-Line Medication

Pharmacy Times

Clinically meaningful lowering of blood pressure through reduction in dietary sodium was achieved safely and rapidly in 1 week in a middle-aged and elderly cohort.

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NYU radiologists tackle the challenge of making MRI machines less expensive

STAT

How many radiologists does it take to build a working MRI from scratch? New York University radiologists Leeor Alon and Tobias Block wanted to find out. The two hosted 50 researchers in New York City last month, and over the course of five days, managed to build a small, low-field MRI. Alon and Block are currently fine-tuning its imaging abilities. The overarching message of the gathering: MRIs don’t need to be as expensive as they currently are.

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Data Show Benefit of Intensive Blood Pressure Reduction Is Consistent in East Asian Population With Hypertension, High Cardiovascular Risk

Pharmacy Times

The SPRINT trial was the first to demonstrate the benefit of further reduction in blood pressure, but it included a limited Asian population and excluded patients with diabetes or history of stroke.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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STAT+: Novo Nordisk wants to be a cardiovascular company, too, with sights set on inflammation

STAT

PHILADELPHIA – Novo Nordisk, which has dominated the diabetes and obesity markets with its blockbuster drugs Ozempic and Wegovy, now also wants to be a major player in heart disease. The landmark Select trial presented over the weekend – which showed Wegovy significantly cut the risk of heart complications – is just one of many efforts by the Danish drugmaker to expand into the cardiovascular space.

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Where old pathways to innovative cancer care fall short, a new model emerges

pharmaphorum

Where old pathways to innovative cancer care fall short, a new model emerges Mike.

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Pharmacy Focus: Policy Edition - Navigating the Reimbursement Maze

Pharmacy Times

Tune in to this episode of Pharmacy Focus: Policy Edition for an update on the ever-evolving landscape of pharmacy reimbursements, pharmacy benefit manager reform, and direct and indirect remuneration fees.

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Optimizing KOL engagement and technology utilization in 2024

PharmaVoice

What if your advisory solution was a skillful blend of innovative tech, medical communications specialists, high-touch client service, and a flexible contract?

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Data Show Lepodisiran Was Well Tolerated, Substantially Lowered Lipoprotein (a)

Pharmacy Times

Elevated Lp(a), which was previously untreatable, may become treatable in the near future, according to the study investigator.

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STAT+: Michigan bill that would pare back pharma liability shield law moves closer to enactment

STAT

A one-of-a-kind law in Michigan that prevents the state government and residents from suing pharmaceutical companies over injuries caused by their medicines is poised to be pared back. A bill designed to allow product liability lawsuits to be filed against drug companies passed the Michigan Senate last month and then passed the House last week. The legislation , which won overwhelming majorities in both chambers but was opposed by the Michigan Chamber of Commerce and a pharmaceutical industry tr

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SELECT Trial Data Show Benefit of Semaglutide in Patients With Obesity

Pharmacy Times

The SELECT trial expands on existing literature that have shown safety and cardiovascular benefit in individuals with diabetes to now also show benefit in obesity.

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STAT+: Patients loved Carbon Health’s diabetes program. That couldn’t save it

STAT

A diabetes diagnosis was not what Jason had in mind when he set out on a cross-country road trip with his family in the fall of 2021. He had been heavy since he was a kid, but he always had felt pretty healthy — until getting home to the San Francisco Bay Area, when he started to notice his body doing strange things. “It kind of came out of nowhere,” said Jason, who asked to keep his last name private.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Upcoming Phase 3 Trials to Evaluate Efficacy, Safety of Milvexian in Patients with Cardiovascular Conditions

Pharmacy Times

Harrington discusses how the performance of milvexian in prior phase 2 trials focused on different patient populations creates the foundation for future research.

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Victoria Atkins replaces Barclay as UK health secretary

pharmaphorum

Victoria Atkins replaces Barclay as UK health secretary Phil.

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NACDS’ health, wellness initiatives take center stage at 2023 Milken Institute Future of Health Summit

Drug Store News

NACDS’ initiatives regarding health and wellness were on display at the 2023 Milken Institute Future of Health Summit.

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Akili says OTC switch for ADHD DTx leads to sales rise

pharmaphorum

Akili says OTC switch for ADHD DTx leads to sales rise Phil.

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Opinion: Congress must reauthorize the National Advisory Committee for Seniors and Disasters

STAT

With the election of Rep. Mike Johnson as speaker of the House, the urgent and important work of passing appropriations and vital national security legislation is now advancing. But it is also the time to address additional important issues affecting the well-being of Americans, such as one highlighted during the Covid-19 pandemic as well as recent wildfires and hurricanes: the care and support for America’s most vulnerable.

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UCB on course for approval of gMG drug Rystiggo in EU

pharmaphorum

UCB on course for approval of gMG drug Rystiggo in EU Phil.

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Walgreens Boots Alliance sells shares of Cencora for $674M of initial proceeds

Drug Store News

Walgreens Boots Alliance said there will be no changes to its ongoing collaboration and long-term strategic partnership with Cencora.

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ADCs shine at ESMO ’23, as pharma makes case for early immunotherapy interventions

pharmaphorum

ADCs shine at ESMO ’23, as pharma makes case for early immunotherapy interventions Mike.

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Organic India launches Tulsi Tumeric Chai

Drug Store News

The company said Tulsi Turmeric Chai, the newest tea flavor, is one in which classic chai spices meet golden turmeric.

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Rivaroxaban Demonstrates Favorable Benefit-Risk Profile in Fragile Populations with Peripheral Arterial Disease

Pharmacy Times

Bonaca also notes that pharmacists can play a key role in educating patients and clinicians about the appropriate use and dosing of antithrombotic drugs for vascular protection.

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Equity for Women in Healthcare: 131 Years is Too Long to Wait

PharmExec

Closing the gender gap in pharma—and how we get there together.

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FDA grants orphan drug designation to MAIA’s glioblastoma agent  

Pharmaceutical Technology

As per the company, the candidate THIO, is the only direct telomere-targeting agent currently in clinical development.

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Novel siRNA therapeutic could lower cardiovascular disease risk

European Pharmaceutical Review

A single dose of lepodisiran, a small interfering RNA ( siRNA ) therapeutic, produced over 94 percent reductions in blood levels of lipoprotein(a), also known as Lp(a), with the results lasting for nearly a year, findings from a Phase I trial show. Lepodisiran Lepodisiran is a siRNA therapeutic that blocks the messenger RNA needed to manufacture a key component of lipoprotein(a) in the liver.

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Rite Aid Healthy Futures awards $4.6M in grant funding through 2023 Connecting Communities program

Drug Store News

Nearly 40 children’s hospitals across 14 states have received funding to combat food insecurity.

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Could GSK myelofibrosis treatment gain EU-first approval?

European Pharmaceutical Review

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for GSK’s momelotinib, recommending marketing approval. The Committee deemed it beneficial as a treatment for disease-related splenomegaly (enlarged spleen) or symptoms in adults with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus kinase (JAK) inhibitor n